Bracket Welcomes New Chief Technology Officer Sam Whitaker

Wayne, PA – Bracket, a leading clinical trial technology and specialty services provider, today welcomed Sam Whitaker as Chief Technology Officer (CTO) to its growing team. Whitaker joins Bracket’s leadership team bringing ten years of experience in clinical technology and global infrastructure innovation to the Company.

Whitaker will be responsible for Bracket’s global product strategy, management and innovation, technology development and engineering including architecture, user experience (UX), user interface (UI) and IT support functions. Whitaker will leverage his ten years’ experience as co-founder and CEO of Greenphire, the first clinical technology to bring payment technology to the clinical environment.

During his tenure at Greenphire, Whitaker invented and successfully commercialized the first clinical trial payment technologies. The web-based applications were built on top of a global technology infrastructure, which he and his team designed to support the unique needs of sponsors, clinical research organizations (CROs) and sites and scaled to support more than 500 clients globally.

“Sam Whitaker joins Bracket with highly specific knowledge of clinical trial technology and a complete understanding of our technological vision,” said Jeff Kinell, CEO of Bracket. “As we continue to solidify our position as a global leader in clinical trial technology and specialty services, it’s imperative that we partner with our industry’s most innovative minds to lead and implement industry-wide advancements.”

Prior to Greenphire, Whitaker worked in the product division of Citigroup, designing technology solutions across verticals. He graduated from the University of Pennsylvania.

About Bracket

Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Bracket Expands Team with Industry Leader Dr. Amir Kalali

Wayne, PA – Bracket, a leading clinical trial technology and specialty services provider, today introduced Amir Kalali, MD, as its Executive Advisor for Global Strategy . Dr. Kalali joins Bracket as a recognized leader in drug development methodology and technological innovation.

Dr. Kalali will work with Bracket’s leadership to help identify innovative technologies to support the evolution of its integrated growth. In addition, Dr. Kalali will assist in the acceleration of growth in Bracket’s CNS product lines in other fields of medicine.  He is Professor of Psychiatry at University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development, published by Cambridge University Press. He has authored over 150 peer-reviewed publications.

Previously, Dr. Kalali was Global  Head of the Neuroscience Center of Excellence at Quintiles IMS, where he was responsible for the enterprise-wide strategy for neuroscience, encompassing drug development and healthcare services.

Recognized globally as a leader in drug development and healthcare with an emphasis on  innovation, collaboration, and the intersection with new technology, Dr. Kalali was the Founding Chairman of the Executive Committee of the International Society for CNS Drug Development  (ISCDD), a founding member of the International Society for CNS Clinical Trials and  Methodology (ISCTM), where he serves on Executive Committee, the Scientific Committee, and  previously chaired the Membership and Publication Committees. He is also a founder and Co- Chair of the Scientific Program Committee of the CNS Summit, and serves on the Scientific Program Committee of the American College of Neuropsychopharmacology. Dr. Kalali regularly presents at national and international scientific meetings, and lectures  frequently on drug development, innovation, technology, digital medicine and health.  He is an advisor to the Center for Digital Transformation at the Paul Merage School of Business  at the University of California, Irvine.

“We are  thrilled  to welcome Dr. Kalali to Bracket,” said David G. Daniel, MD, Senior Vice President and Chief Medical Officer of Bracket. “Dr. Kalali’s depth and breadth of knowledge of clinical trial methodology and emerging technologies is unparalleled. We anticipate that Dr. Kalali will become a major contributor to Bracket’s  growth in eCOA, rater training and data quality monitoring solutions.” During his career, Dr. Kalali has been recognized five times by PharmaVOICE magazine as one of the 100 most inspiring leaders in life sciences. In 2014, he was awarded the PharmaVOICE Red Jacket Award in recognition of his career-long contributions to the industry.

Dr. Kalali earned his medical degree from the University of London and completed his psychiatry training at University College and Middlesex School of Medicine, University of London.

About Bracket
Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

The Industry’s Need for an Advanced and Transformative IRT Solution

Byprimerano-jim Jim Primerano, Sr. Vice President and General Manager, eClinical at Bracket

Interactive Response Technology (IRT) is vital in managing the patients and drug supplies involved throughout all stages of clinical trial studies, but the most effective IRT systems offer more advanced functionality and seamless software integration. When these elements combine with innovations in user acceptance testing (UAT) and standardized delivery integration, the result is a next-generation IRT. This must-have technology streamlines automation processes to allow for rapid study deployment that integrates standardized delivery requirements, supports the majority of trial constructs and furthers the adoption of digitization in the life science industry.

Today, it exists in the form of the newly released Bracket CUBETM, an IRT solution that allows for streamlined, rapid trial deployment that increases the efficiency of clinical trials. When selecting an IRT to manage complex studies and connect clinical trial sites and supply chains, consider the core components and key benefits of this type of modern IRT solution.

  • A feature-rich configuration framework

An advanced IRT system is configured using an iterative UAT to lay the groundwork for a streamlined deployment process. Its capabilities allow sponsors to effortlessly leverage RTSM benefits without the associated constraints of time and cost. The model is easy to implement and aims for increased trial efficiency by deemphasizing requirement documentation and instead prioritizing unique configuration needs to enable superior statistical outcomes.

  • Rapid and streamlined study deployment

With this IRT solution, sponsors can deploy studies in one to two weeks through a UAT process that lets a study team fully visualize the RTSM system. This accelerates timelines and improves efficiency for all those involved, eliminating the need for pre-approved system requirement documentation. An advanced IRT supports most trial design constructs and focuses on a quick, user-accepted solution.

  • Collaborative user-centric configuration

A user acceptance build experience that welcomes engagement sets the new standard for the way sponsors collaborate to deploy IRT. With a rapid project lifecycle, this IRT lets sponsors experience the system prior to requirements approval. Its robust functionality supports an automated deployment process and makes it an easy to use, productive tool for clinical trial management.

Bracket has recently introduced CUBE, a transformative next-generation IRT solution for the life science industry, to its suite of configurable clinical research solutions. This new product leverages an iterative user acceptance build experience and Bracket’s full RTSM platform to streamline and accelerate study deployments. Possessing all the above qualities of a modern IRT system, CUBE is an advanced implementation model that balances cost and value creation for biotech and pharma sponsors.

For more information on interactive response technology and Bracket CUBE, click here.

Bracket Introduces Transformative IRT Solution, CUBE™, to Biotech and Pharma Sponsors

WAYNE, Pa — Bracket, a leading clinical trial technology and specialty services provider, announced today the release of CUBETM, a transformative interactive response technology (IRT) solution for the life sciences industry. Designed through an iterative user acceptance build experience, CUBE will be immediately available to qualifying biotechnology and pharmaceutical trial sponsors through Bracket.

The solution will enable biotech and pharma sponsors to utilize an innovative new solution to deploy studies in one to two weeks. It leverages an iterative user acceptance build experience to provide a rapid and advanced deployment methodology without the time and cost constraints of traditional IRT solutions. Key highlights of CUBE for biotech and pharma sponsors of any size include:

  • Accelerate times for sponsors and improves efficiency for CROs
  • Leverages Bracket’s full RTSM platform, but streamlines deployment through automation
  • Rapid project lifecycle lets sponsors experience the system prior to requirements approval
  • Reduce lengthy turnaround times for enhancements and in-study changes

“We’re so pleased to introduce CUBE to the life sciences marketplace and are confident that its easy-to-implement nature will improve the process of managing clinical supplies,” said Jeff Kinell, CEO at Bracket. “By deemphasizing requirement documents and prioritizing unique configuration needs, CUBE will undoubtedly evolve the paradigm of how sponsors collaborate to deploy IRT.”

The platform’s iterative UAT process allows study teams to visualize the RTSM system during the kick off meeting. This accelerates timelines for sponsors and improves efficiency for CROs. CUBE also leverages Bracket’s full RTSM platform, but streamlines the deployment of configuration profiles through automation. It’s intended to support most trial design constructs.

For more information, please visit www.bracketglobal.com/CUBE/.

About Bracket
Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Why Cloud Hosting can be the right choice for Clinical Trial Inventory Management Solutions

Byprimerano-jim Jim Primerano, Sr. Vice President and General Manager, eClinical at Bracket

As sites, sponsors and clinical research organizations (CROs) continue to manage more complex trial inventory, frequently on an international level, the need for an end-to-end clinical trial management solution that will ensure inventory is regulated in an FDA compliant manner is critical. Small to mid-sized companies often face challenges implementing these solutions, due to the complex IT infrastructure requirements, associated third-party costs and lack of in-house resources to maintain and manage the solution. These roadblocks highlight the advantages of a cloud-based solution, which is what Bracket is now offering for our SmartSupplies suite.

If you are considering upgrading from static Excel spreadsheets to intelligent inventory management software, consider how a cloud-based solution will benefit your organization almost immediately.

  • Saves money by reducing third-party management costs and overall IT footprint

In addition to being competitively priced and with reports demonstrating cloud-based services to reduce expenses by 50%, a solution hosted in the cloud will dramatically reduce third-party costs. Cloud hosting eliminates the need for hardware maintenance and management, thereby reducing the need for costly off-shore contractors and vendors. For companies without their own IT infrastructure and servers in place, a cloud-based solution eliminates the need to configure that framework – and instead, allows the company to focus on benefitting from the application itself.

  • Ensures compliance through proactive yet non-disruptive system health-checks

The transparency provided by cloud-hosted solutions allows your vendor to proactively monitor the software, push out updates and ensure all components are compliant with the latest FDA regulations. For example, your software provider can see if your organization is properly allocating memory space, if and when the infrastructure is aging and work to proactively mitigate the issues. Ultimately, the transparency of the cloud will allow your organization to focus first and foremost on running your clinical trial smoothly, rather than on incessant maintenance of your IT infrastructure.

  • Enables better collaboration across sites and easier integration with other eClinical systems

The smartest clinical trial inventory management software solutions are designed to facilitate end-to-end materials management for sponsors and enable greater collaboration. When hosted in the cloud, all involved parties – from clinical research associates to end-users – can seamlessly and instantaneously share data, regardless of geography. For clinical research associates who are running study management around the globe or for organizations who have thousands of end-users managing inventory at a site, it’s important to have easy and instant access to a shared database.

For more information on cloud-hosted inventory management solutions, click here.

Bracket Announces Launch of Cloud-Based Version of SmartSupplies

Wayne, Pa — Bracket, a leading clinical trial technology and specialty services provider, today announced the launch of a cloud-based service for SmartSupplies, its clinical trial inventory management software suite. This launch marks the first hosted solution of SmartSupplies since Bracket’s acquisition of CLINapps in 2016 and is applicable to all modules of the SmartSupplies suite.

SmartSupplies, an enterprise clinical trial material management software solution, provides end-to-end clinical inventory management for sponsors. The release of the cloud-based offering will enable companies without their own IT infrastructure and servers to easily and securely run and manage the application. Built atop Oracle Cloud Services, the cloud-hosted solution will facilitate enhanced integration with other eClinical systems as well as allow end users and clinical research associates (CRAs) to share data seamlessly and instantaneously without geographic constraints.

“We are pleased to introduce a cloud-based hosting option for SmartSupplies to our existing and new customers,” said Jeff Kinell, CEO of Bracket. “The benefits of cloud hosting continue to present themselves, especially as clinical trials worldwide rely more on immediate collaboration across sites.”

Bracket’s hosted SmartSupplies solution is competitively priced and provides a cost-effective alternative for sponsor companies deploying the enterprise solution. This cloud-based option allows sponsors to eliminate in-house hardware maintenance and management for a reduced IT footprint.  Other advantages include:

  • Reducing outsourced hosting, off-shore contractors and vendors for decreased third-party costs;
  • Enabling proactive support and system health-checks from Bracket’s support team;
  • Facilitating better integration with other eClinical systems and collaboration across sites; and
  • Ensuring a well-maintained regulatory environment and robust business continuity.

The transition of SmartSupplies to the cloud is seamless for existing customers, causing no disruption to the end user.

“Offering customers the option of cloud hosting for SmartSupplies was born out of necessity,” said Kinell. “We want sponsors to focus their energy and efforts on running clinical trials, not on managing their IT infrastructure – and hosting SmartSupplies in the cloud will alleviate that burden.”

About Bracket
Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Bracket Community Events this Spring

MS Walk (Walk to Fight MS)

This walk was hosted on Sunday, April 30th   in Downtown Phoenixville.  Some of our Bracket employees in our Wayne, PA office participated in the MS Walk and wore orange shirts walking the trail for awareness.  To find out more about the MS walk, please visit the website here: MS Walk.

Upcoming Walk:
Anti-Defamation League (ADL) -Walk Against Hate – May 21 in Philadelphia, PA

Our next walk Bracket will be attending is the Anti-Defamation League (ADL) -Walk Against Hate. ADL’s 7th annual WALK Against Hate on Sunday, May 21, 2017 from 9:00am-12:00pm to take part in a one of a kind initiative in which people from various backgrounds are united to make strides toward embracing diversity. This is an opportunity for all of us to stand together against bigotry and hatred in our own community and we’re inviting all of our friends, family, and neighbors to join us when we lace up our sneakers to WALK Against Hate. Learn more on Anti-Defamation League (ADL)-Walk Against Hate.

 

 

 

 

Bracket Among the First Providers to Initiate BYOD ePRO Clinical Research Study in Japan

Wayne, Pa —Bracket, a leading clinical trial technology and specialty services provider, today announced the launch of a new Bring Your Own Device (BYOD) electronic patient-reported outcome (ePRO) study in Japan.  This study highlights the importance of BYOD use in clinical studies as an integral component of electronic clinical outcomes assessments (eCOA). Bracket is among the first to utilize BYOD in a randomized clinical trial in Japan.

The use of BYOD in clinical research is the next crucial stage in continuing to embrace the technology that has fundamentally improved the way studies are conducted. BYOD adoption is slowly gaining momentum, but the many ways it has enhanced the effectiveness of clinical research serve as an argument for why mobile support should become an essential element of other eCOA platforms.

Bracket’s own next-generation platform, Bracket eCOA™, integrates with several devices to support ePRO, eClinRO and eObsRO use, supplementing a BYOD approach. Allowing patients to collect and report data in a central location through easy-to-use mobile applications increases patient engagement and improves data quality.

“eCOA is an extremely important research tool and the increasing adoption of BYOD is highly beneficial for the industry on a global scale,” said Jeff Kinell, CEO at Bracket.

Bracket Patient Diary is a native app that allows patients in clinical trials to use their own smartphones to complete questionnaires about their symptoms, medication use, and quality of life. Bracket Patient Diary has been in use in clinical trials since 2014 and is available for Android and iOS.

About Bracket
Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Using eCOA to Assist with the MDS-UPDRS

By Adam Butler, Sr. Vice President, Strategic Development

Bracket announced this week that we are beginning work on new, electronic versions of the MDS-UPDRS and UDysRS for use in clinical trials. Developing eCOA versions of these scales, like all other clinical outcomes, will help to make research more efficient. But there are some components of these scales that are especially important to consider.

Endpoint Reliability

An important part of the work Bracket does with clinical outcomes is not only developing the tools that allow for better reporting and collection of data at the sites, but in doing the quality assurance work once the data has been submitted. Tracking and analyzing the integrity of the data submitted, and ensuring that clinicians are following scoring conventions, protocol standards, and monitoring for potential data variances.

Scoring Calculation Example from the MDS-UPDRS

With an outcome like the MDS-UPDRS, when the data is collected using Bracket’s Rater Station, careful timestamping can record the time for administration of individual sub tasks, for example, and ensure that they are being administered in accordance with the protocol, or track for significant outliers in administration times for individual patients or trial sties.

In addition, Bracket has shown in the past that a potential source of site variability can be a confounding of the Left and Right symptom scores in the Motor Examination portion. Collecting these scores using eCOA allows for an efficient QA check to ensure that these are being reported consistently.

Prompted Interviews

An important element of Bracket’s Rater Station is our use of a “Prompted Interview,” which allows for specific prompts and questions to be given to a rater during administration of a scale. Our intelligent scale approach allows for these prompts to be automated. In Part 1A of the MDS-UPDRS, for example, uses a “Stem and Probe” approach to clarify symptom severity. These probes can be programmed into the Rater Station, giving the clinician additional support during the clinical interview to ensure the scores are recorded accurately.

Scoring Automation

Some elements of the MDS-UPDRS require the clinician to do some simple math to determine an item score. While these calculations are relatively straight-forward, they can be a source of variance if not checked carefully. When administering and collecting the MDS-UPDRS electronically, these tasks are automated.

Stem and Probe Example from the MDS-UPDRS

 

Improving Data Quality

Combining well-design eCOA tools with proven Quality Assurance measures is one way to help improve data quality in clinical trials. Hopefully the implementation of these important scales from MDS can be useful in furthering clinical research for these diseases.

 

 

Read our press release on MDS-UPDRS here.  Please contact us if you would like additional information.

Bracket to Develop Electronic Versions of MDS-UPDRS and UDysRS for Parkinson’s Disease Trial Assessments

Wayne, PA., — Bracket, a leading clinical trial technology and specialty services provider, today announced an agreement with the International Parkinson and Movement Disorder Society (MDS), to develop electronic versions of the MDS-Unified Parkinson’s disease Rating Scale (MDS-UPDRS) and the Unified Dyskinesia Rating Scale (UDysRS). The migration of these complex scales to an electronic clinical outcome assessment (eCOA) format aims to improve trial conduct and data quality for Parkinson’s disease (PD) studies.

The increasing prominence of PD, a progressive disorder of the nervous system that affects movement, drove MDS to prioritize the update of its scales. Today more than 10 million people worldwide are living with the condition, and each year 60,000 people are newly diagnosed in the United States alone.

Bracket has extensive experience working with paper-and-pencil clinical outcomes in Parkinson’s disease and other movement disorders. Bracket is creating eCOA versions of the MDS-UPDRS and UDysRS to support efforts to improve data quality in these studies. Both scales require careful clinical interviews of patients, and by migrating these instruments from paper records to eCOA platforms, investigators and pharmaceutical sponsors will be equipped with a more effective method for using these outcomes in clinical trials.

“Clinical trials in Parkinson’s disease and other movement disorders are extremely complex and have a high failure rate,” said Jeff Kinell, CEO of Bracket. “Fortunately, digitization in clinical trials is improving results, as the logic of eCOA streamlines scoring protocols and compliance. We’re proud to partner with MDS to advance PD trials and help address the growing prevalence of the disease at the ground level.”

The UPDRS was developed in the 1980s and is the most widely used rating scale for PD in clinical trials. The revision, known as the MDS-UPDRS, was released in 2008 and measures mentation, behavior and mood, activities of daily living and motor functions. The UDysRS evaluates involuntary movements associated with treated PD, measuring on-dyskinesia, off-dystonia, impairment and disability.

The MDS-UPDRS and UDysRS scales are prime candidates for digitization as eCOA will streamline specific trial protocols, including the addition of time stamps associated with administration to ensure scales are administered appropriately. Additionally, eCOA will simplify calculations on how much time subjects report experiencing dyskinesia, dystonia and an “off” state.

About Bracket
Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.